Model 1100 Cold Therapy Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K955057 ↗

FDA Product Code

ILO

Device Class

Class II

Regulation

21 CFR Part 890.5720

Advisory Committee

Physical Medicine

FDA Decision

SN

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  FDA 510(k) K962462 Active Cleared 23 Sep 1996

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  FDA 510(k) K932592 Active Cleared 18 Mar 1994

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  FDA 510(k) K951350 Active Cleared 23 Jun 1995

• Rounded Cannulated Inside-Out (Rci) Acl Screw

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  FDA 510(k) K932862 Active Cleared 10 Mar 1994

See all devices from Smith and Nephew Donjoy, Inc. →

• What is the Model 1100 Cold Therapy Device used for?

  The Model 1100 Cold Therapy Device is designed to deliver controlled cold therapy to targeted areas of the body. It helps reduce inflammation, swelling, and pain, particularly in musculoskeletal conditions. This makes it useful in physical medicine settings for managing acute or chronic injuries, post-surgical recovery, or chronic pain management.

• Is the Model 1100 Cold Therapy Device reusable or single-use?

  The Model 1100 Cold Therapy Device is supplied as a reusable system. It is intended for repeated use in both clinical and home settings, provided it is cleaned and maintained according to the manufacturer’s guidelines. Reusability helps ensure cost-effectiveness and consistent performance over time.

• What are the key specifications or features of this device?

  The device operates by circulating chilled water through a pack to apply therapeutic cold. It falls under FDA product code ILO and has been cleared under the 510(k) pathway (K955057). The device is classified as Class II and is intended for cold therapy applications only. No MRI safety information is provided, and it is not sterile.

• How should the Model 1100 Cold Therapy Device be stored?

  While the device itself is reusable, the manufacturer’s guidelines must be followed for cleaning and maintenance to ensure proper functionality and hygiene. Storage should be in a clean, dry environment, away from direct sunlight or extreme temperatures, to prevent damage to the device’s components. Always refer to the manufacturer’s instructions for specific storage recommendations.

• What regulatory approvals does the Model 1100 Cold Therapy Device hold?

  The Model 1100 Cold Therapy Device holds FDA 510(k) clearance (K955057) and is classified under Class II with special controls. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device for some indications, specifically within the realm of physical medicine.